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Adverse events and technical complaints related to central venous catheters marketed in Brazil
Morais, Luciene de Oliveira; Friedrich, Karen; Melchior, Stela Candioto; Silva, Michele Feitoza; Gemal, Andre Luis; Delgado, Isabella Fernandes Delgado.
  • Morais, Luciene de Oliveira; Fundacao Oswaldo Cruz. Rio de Janeiro. BR
  • Friedrich, Karen; Fundacao Oswaldo Cruz. Rio de Janeiro. BR
  • Melchior, Stela Candioto; Fundacao Oswaldo Cruz. Rio de Janeiro. BR
  • Silva, Michele Feitoza; Fundacao Oswaldo Cruz. Rio de Janeiro. BR
  • Gemal, Andre Luis; Fundacao Oswaldo Cruz. Rio de Janeiro. BR
  • Delgado, Isabella Fernandes Delgado; Fundacao Oswaldo Cruz. Rio de Janeiro. BR
Rev. bras. hematol. hemoter ; 35(3): 192-197, jun. 2013. tab, graf
Artículo en Inglés | LILACS | ID: lil-681966
ABSTRACT

Aim:

The objective of this study was to critically analyze data of the National Notification System for Adverse Events and Technical Complaints (Notivisa) related to central venous catheters, through an evaluation of the description of notifications recorded between 2006 and 2009.

Methods:

Notifications were categorized and evaluated to (i) determine the number of adverse events and technical complaints, (ii) verify compliance with the classification criteria defined by the legislation, (iii) reclassify notifications, when necessary, in order for them to fit in with the legal definitions, (iv) verify registered companies in Brazil, (v) quantify the notifications according to the registered company and product lot, and (vi) identify the country of original of the notified product. Microsoft Excel® 2010 was used to categorize and systematize the data.

Results:

Some conceptual errors and incomplete records were found. Altogether, 228 notifications of technical complaints and 119 of adverse events were identified. Some notifications on guidewires and broken catheters were reported which led to the necessity of duplicating some medical procedures and to the occurrence of lesions/lacerations of vessels and tissue injury. Forty-seven percent of companies presented at least one notification in Notivisa and in all, 38 product lots had more than one notification.

Conclusion:

These data support a necessity for cooperation between all entities of the ...
Asunto(s)


Texto completo: Disponible Índice: LILACS (Américas) Asunto principal: Vigilancia Sanitaria / Agencia Nacional de Vigilancia Sanitaria / Catéteres / Catéteres Venosos Centrales Tipo de estudio: Estudio pronóstico / Estudio de tamizaje País/Región como asunto: America del Sur / Brasil Idioma: Inglés Revista: Rev. bras. hematol. hemoter Asunto de la revista: Hematología Año: 2013 Tipo del documento: Artículo País de afiliación: Brasil Institución/País de afiliación: Fundacao Oswaldo Cruz/BR

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Texto completo: Disponible Índice: LILACS (Américas) Asunto principal: Vigilancia Sanitaria / Agencia Nacional de Vigilancia Sanitaria / Catéteres / Catéteres Venosos Centrales Tipo de estudio: Estudio pronóstico / Estudio de tamizaje País/Región como asunto: America del Sur / Brasil Idioma: Inglés Revista: Rev. bras. hematol. hemoter Asunto de la revista: Hematología Año: 2013 Tipo del documento: Artículo País de afiliación: Brasil Institución/País de afiliación: Fundacao Oswaldo Cruz/BR